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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, vitamin d
510(k) Number K113546
Device Name ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Original Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Original Contact michael leuther
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX   JJY  
Date Received12/01/2011
Decision Date 07/24/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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